Orange Book product · Brand (NDA)
DARTISLA ODT
GLYCOPYRROLATE
At a glance
Oct 11, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 11, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYCOPYRROLATE
Strength
0.85MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 215019
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2022GLYCOPYRROLATEBrand (NDA)
NDA 214919 · FRESENIUS KABI USA
- 2018GLYRX-PFBrand (NDA)
NDA 210997 · EXELA PHARMA
- 2017LONHALA MAGNAIR KITBrand (NDA)
NDA 208437 · SUMITOMO PHARMA AM
- 2015SEEBRI NEOHALERBrand (NDA)
NDA 207923 · NOVARTIS
- 2010CUVPOSABrand (NDA)
NDA 022571 · MERZ PHARMS
- —ROBINULBrand (NDA)
NDA 017558 · HIKMA
- —ROBINULBrand (NDA)
NDA 014764 · ROBINS AH
- 2026GLYCOPYRROLATEGeneric (ANDA)
ANDA 216910 · QUAGEN
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 220062 · BIONPHARMA
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 219267 · AJENAT PHARMS
- 2025GLYCOPYRROLATEGeneric (ANDA)
ANDA 216084 · MSN
- 2024GLYCOPYRROLATEGeneric (ANDA)
ANDA 214847 · AUROBINDO PHARMA LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
